Procope Medicals

Procope Medicals

The new challenge of MedTech : Between innovations, regulations and compliance challenges

MedTech, at the crossroads of technology and healthcare, is shaping the development of medical devices with a relentless quest for innovation. In this dynamic landscape, several elements are redefining the design of these devices, with major implications for manufacturers.

A boundless quest for innovation ?

The medical sector is in a state of flux, propelled by technological advances and the urgency created by the global health crisis. MedTech companies are engaged in a frantic race for innovation, encouraged by government initiatives such as France 2030, which aims to put France at the forefront of medical innovation in Europe.

medtech réglementation
réglementation dispositif médical

How do you navigate an ever-changing landscape ?

Medical regulations, once stable, are undergoing constant change. Digital technologies, and in particular connected medical devices, mean that existing standards have to be adjusted rapidly. In Europe, new regulations on medical devices require manufacturers to meet stricter standards, sometimes accompanied by the need to recertify their products. This rapid evolution underlines the importance of keeping up with regulations to guarantee the quality and conformity of medical devices. The new regulation specific to medical devices came into force in May 2021, retaining the fundamentals of the CE marking approach but reinforcing a number of requirements, such as an extended scope of application, improved vigilance arrangements, and enhanced pre-market assessment.

Adapt to an increasingly complex digital environment

Medical devices are becoming extra-complex, generating major data security and cybersecurity issues. Compliance management is becoming a central challenge, threatening both the bottom line and the reputation of companies in the sector. Agile navigation of this complex landscape is becoming imperative to ensure quality, reliable and standards-compliant products, while making a positive contribution to the global evolution of healthcare.

Today, medical device manufacturers are facing unprecedented challenges, and Procope Medicals is taking the full measure of these regulatory developments to ensure the compliance of its artificial heart device.

développement dispositif médical